EUROLAB
usp-2072-disintegration-for-veterinary-bolus-tablets
Dissolution and Disintegration Testing EMA Guideline on the Investigation of Bioequivalence—Dissolution CriteriaFDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage FormsFDA QbD Dissolution Modeling for PAT IntegrationICH M9 Biopharmaceutics Classification System-based BiowaiversICH Q1A(R2) Stability Testing Impacting Dissolution RateICH Q3C (R8) Residual Solvent Impact on DissolutionICH Q6A Dissolution Testing as Part of SpecificationsICH Q8(R2) Design Space and Dissolution ProfilesICH S6 Dissolution Testing in Biotech-Derived ProductsISO 22609:2004 Disintegration Time of Medical Face Mask MaterialsISO 31101:2019 Dissolution Testing of Oral Hygiene ProductsJP 15th Edition: Dissolution and Disintegration TestJP 3.09 Disintegration Test for Capsules and TabletsJP General Chapter 6.10 Dissolution Test for SuppositoriesPh. Eur. 2.9.1 Disintegration Test for Solid Dosage FormsPh. Eur. 2.9.29 Disintegration of Tablets for Veterinary UsePh. Eur. 2.9.3 Dissolution Testing of Oral Dosage FormsPh. Eur. 2.9.39 Dissolution of Patches and ImplantsPh. Eur. 2.9.4 Dissolution of Modified Release Dosage FormsPh. Eur. 2.9.40 Dissolution Testing for Oral SuspensionsPh. Eur. 2.9.43 In Vitro Dissolution Testing of Inhaled ProductsPh. Int. 2.9.5 Disintegration Testing of SuppositoriesUSP <1002> Dissolution Testing for Powder-Filled CapsulesUSP <1004> Disintegration Testing of Vaginal TabletsUSP <1087> Assessment of Drug Release from Extended Release TabletsUSP <1088> In Vitro Dissolution Profile Comparison for Generic DrugsUSP <1090> Assessment of Drug Release from Liposomal Dosage FormsUSP <1091> Assessment of Drug Release from MicrospheresUSP <1092> Dissolution Procedure Development and ValidationUSP <1094> Capsules—Dissolution and DisintegrationUSP <1097> Dissolution Testing for Transmucosal Drug Delivery SystemsUSP <2040> Dissolution Testing for Dietary SupplementsUSP <2041> Dissolution Testing of Oral Disintegrating TabletsUSP <2042> Disintegration and Dissolution of Buccal TabletsUSP <2043> Disintegration Testing of Chewable TabletsUSP <2044> Disintegration Testing for Orally Disintegrating TabletsUSP <2045> Dissolution of Transdermal PatchesUSP <2046> Disintegration of Medicated LozengesUSP <2047> Dissolution for Vaginal RingsUSP <2048> Dissolution for Oral Thin FilmsUSP <2049> Disintegration of Drug-Eluting StentsUSP <2050> Dissolution of Topical Creams and GelsUSP <2051> Dissolution Testing for Ion Exchange Resin-Based FormulationsUSP <2052> Disintegration of Controlled-Release TabletsUSP <2053> Dissolution Testing for Suppositories and PessariesUSP <2054> Disintegration Test for Extended-Release Film-Coated TabletsUSP <2055> Dissolution of Chewable GumsUSP <2056> In Vitro Drug Release for Implantable DevicesUSP <2057> Dissolution for Combination Drug ProductsUSP <2058> Dissolution for Oral Pellets and GranulesUSP <2059> Disintegration Testing of Oral Dispersible FilmsUSP <2060> In Vitro Release of Drug from Polymeric MicrospheresUSP <2061> Dissolution Testing of Nanocrystal FormulationsUSP <2062> Disintegration Testing for Multi-Layer TabletsUSP <2063> In Vitro Release Testing of Injectable SuspensionsUSP <2064> Dissolution of Non-Oral Dosage FormsUSP <2065> Disintegration Testing for Delayed Release CapsulesUSP <2066> Dissolution for MinitabletsUSP <2067> Dissolution of Coated Granules in SachetsUSP <2068> In Vitro Drug Release from Dermal SystemsUSP <2069> Disintegration Testing for Mucosal FilmsUSP <2070> Dissolution Testing for Sublingual TabletsUSP <2071> Drug Release Testing for Injectable GelsUSP <2073> Dissolution of Multi-Compartment CapsulesUSP <2074> Disintegration Testing of Gastro-Retentive TabletsUSP <2075> Dissolution Testing for Microemulsion SystemsUSP <2076> Dissolution Testing for Oral JelliesUSP <2077> Disintegration Testing for Modified-Release CapsulesUSP <2078> Dissolution of Floating TabletsUSP <2079> Disintegration Test for Multi-Unit Pellet SystemsUSP <2080> Drug Release from Drug-Eluting CoilsUSP <2081> In Vitro Drug Release Testing for Smart TabletsUSP <2082> Dissolution Testing of Effervescent GranulesUSP <2083> Disintegration Testing for Bilayer TabletsUSP <2084> Dissolution of Mucoadhesive TabletsUSP <2085> Disintegration of Matrix-Formed TabletsUSP <2086> Dissolution Testing of Suspended APIs in Liquid MediumUSP <2087> Disintegration Test for pH-Dependent Release CapsulesUSP <701> Disintegration of Effervescent TabletsUSP <701> Disintegration Testing of Uncoated TabletsUSP <705> Quality Attributes for Powder for Oral SuspensionUSP <711> Dissolution Testing of Immediate Release TabletsWHO Technical Report Series 929 Annex 9—Dissolution Testing for Quality Control

USP <2072> Disintegration for Veterinary Bolus Tablets Laboratory Testing Service: A Comprehensive Guide

The USP <2072> Disintegration for Veterinary Bolus Tablets testing service is a crucial laboratory test that ensures the quality and safety of veterinary bolus tablets. This test is governed by various international and national standards, which are outlined below.

International Standards:

  • ISO 14688:2018 - Disintegration test for tablets

  • ASTM E1096-17 - Standard Test Method for Dissolution of Tablets in Water Using a Paddle or Reciprocating Tester

  • EN 1651:2017 - Disintegration test for solid oral dosage forms

    • National Standards:

  • USP <2072> - Disintegration and dissolution tests for solid oral dosage forms

  • EP 8.4 (EU Pharmacopoeia) - Disintegration test for solid oral dosage forms

    • Standard Development Organizations:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations play a crucial role in developing and maintaining international standards. They ensure that standards are up-to-date, relevant, and meet the evolving needs of industries.

    Evolution of Standards:

    Standards evolve over time as new technologies emerge, and industry requirements change. This ensures that laboratory tests remain effective and relevant to the ever-changing landscape of pharmaceuticals and veterinary medicine.

    This specific test is essential for ensuring the quality and safety of veterinary bolus tablets. The consequences of not performing this test can be severe, including:

  • Product Contamination: Failure to disintegrate can lead to product contamination, which may cause harm to animals.

  • Inadequate Absorption: If a tablet does not disintegrate, the active ingredients may not be absorbed correctly by the animals body, leading to inadequate therapeutic effects or adverse reactions.

  • Product Recalls: In severe cases, failure to conduct this test can result in product recalls, which can damage the reputation of the manufacturer and lead to financial losses.

    • Industries and Sectors:

    This testing service is required for various industries, including:

  • Pharmaceutical manufacturers

  • Veterinary medicine companies

  • Research institutions

  • Government regulatory agencies

    • Quality Assurance and Control:

    Conducting this test ensures that products meet international standards for quality and safety. It helps to maintain customer confidence and trust in the product.

    The USP <2072> Disintegration for Veterinary Bolus Tablets testing service involves a series of steps, including:

  • Sample Preparation: The test sample is prepared according to standard procedures.

  • Testing Equipment: A paddle or reciprocating tester is used to measure the disintegration time of the tablet.

  • Temperature and Humidity Control: The testing environment is maintained at specific temperature and humidity levels.

  • Measurement and Analysis: The disintegration time is measured, and the results are analyzed according to standard procedures.

    • Calibration and Validation:

    All testing equipment must be calibrated regularly to ensure accuracy. Validation procedures are also performed to confirm that the test meets international standards.

    The results of this test are documented in a clear and concise manner, following established reporting standards. The report includes:

  • Test Results: Disintegration time is reported, along with any relevant data or measurements.

  • Conclusion: A conclusion is drawn based on the test results, indicating whether the product meets international standards for quality and safety.

    • Certification and Accreditation:

    Eurolabs laboratory is certified to perform this testing service according to international standards. The certification ensures that our testing procedures meet strict criteria for accuracy and reliability.

    The benefits of performing the USP <2072> Disintegration for Veterinary Bolus Tablets testing service are numerous:

  • Quality Assurance: This test ensures that products meet international standards for quality and safety.

  • Compliance with Regulations: Conducting this test helps manufacturers comply with regulatory requirements, reducing the risk of product recalls and legal consequences.

  • Customer Confidence: By ensuring the quality and safety of veterinary bolus tablets, customers can trust in the reliability of the product.

    • Eurolabs expertise and experience in laboratory testing make us an ideal choice for this service:

  • State-of-the-Art Equipment: Our laboratory is equipped with the latest technology to ensure accurate results.

  • Certified Personnel: Our staff are certified to perform this testing service according to international standards.

  • Accreditation and Certification: We hold accreditation and certification from recognized organizations, ensuring our procedures meet strict criteria for accuracy and reliability.

    • Need help or have a question?
    Contact us for prompt assistance and solutions.

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